CN109247965B

CN109247965B - Suturing device

Info

Publication number: CN109247965B
Application number: CN201811177715.9A
Authority: CN
Inventors: 陈文俊
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2018-10-10
Filing date: 2018-10-10
Publication date: 2021-11-26
Anticipated expiration: 2038-10-10
Also published as: CN109247965A

Abstract

The invention provides a suturing device, which comprises a tubular catheter, a puncture catheter and a suture line catching device, wherein the puncture catheter and the suture line catching device are arranged in the tubular catheter and can slide along the axial direction of the tubular catheter, a through hole is formed in the wall of the tubular catheter, and the suture line catching device can be pushed out of the through hole. The whole device has compact design and convenient operation, does not leave metal in the body, and is safer.

Description

Suturing device

Technical Field

The invention relates to a medical suturing instrument, in particular to a suturing device.

Background

The foramen ovale is a physiological pathway in the embryonic stage of the atrial septum of the heart. The fetus has no pulmonary circulation and oxygenated blood from the umbilical cord flows from the right atrium of the fetus through the foramen ovale into the left atrium. After birth, with the establishment of pulmonary circulation, the pressure in the left atrium increases, and the secondary septum and the primary septum approach each other and are cohered and fused to gradually form a permanent atrial septum. However, if some people are still unfused, Patent Foramen Ovale (PFO) is formed.

In most cases, the pressure in the left atrium of the human heart is greater than in the right atrium, the PFO being in a closed state. In certain circumstances, the PFO tunnel may be pushed open so that the left and right atria form a passageway in front of each other. Emboli from the venous system, which may enter the systemic circulation through PFO channels, manifest as stroke or Transient Ischemic Attack (TIA) if the cerebral arterial system becomes embolized.

Patent foramen ovale is common, and the transcatheter interventional blocking method is to implant a blocking device. Fig. 1 shows a simplified cross-sectional view of a heart. Wherein 1 is the left atrium and 2 is the right atrium. 3 is the secondary compartment (first compartment) and 4 is the primary compartment (second compartment). There is no complete fusion between septum secundum 3 and septum primum 4, forming a PFO tunnel. 10 is a common occluder structure. The occluding device 10 generally comprises two disk-like structures (called disk faces, 11 being a left disk face and 12 being a right disk face) and a thin waist 13 connecting the two disk faces. Occluders are typically made from superelastic metallic materials such as: nickel titanium alloy. Can be compressed into an elongated strip form for delivery from outside the body to the interatrial site along a vascular pathway through a delivery catheter. After delivery to the desired location, the occluding device is released from the delivery catheter and resumes its original two-disc-one-waist configuration. The two

disc surfaces

11, 12 are respectively attached to the left atrium and the right atrium, and the waist 13 is placed in the PFO channel. Thereby leading the secondary septum 3 and the primary septum 4 to be close to and fused with each other. After the device is implanted, the endothelium can grow gradually, and finally the whole double-disc occluder is wrapped to form complete occlusion.

The implanted plugging device has the defects of plugging the patent foramen ovale. After the occluder is implanted, the endothelium wraps the whole occluder, and the occluder loses the function after the PFO is closed. The occluder is generally composed of a metal frame and a flow-blocking membrane of a polymeric material (e.g., PTFE). The blocking device which is out of action can be permanently remained in the atrial septal tissue of the heart of the human body. These residual materials may cause some adverse reactions. For example: wearing tissue around the atrial septum to form perforations, metal hypersensitivity reactions, atrioventricular block, etc. Moreover, some interventional treatment techniques, such as: pulmonary vein ablation, left atrial appendage occlusion, mitral valve intervention replacement/repair, etc., requires puncturing the interatrial septum tissue to establish a passageway to the left atrium. A permanent residual metal stopper will prevent the establishment of the above-mentioned channel.

Disclosure of Invention

Based on this, there is a need for a safer suturing device that avoids metal residue in the body.

A suture device comprises a tubular catheter, a puncture catheter and a suture catching device, wherein the puncture catheter and the suture catching device are arranged in the tubular catheter and can slide along the axial direction of the tubular catheter, a through hole is formed in the wall of the tubular catheter, and the suture catching device can be pushed out of the through hole.

Further, a first inner cavity and a second inner cavity are arranged in the tubular catheter, the first inner cavity extends from the near end to the far end of the tubular catheter, the puncture catheter is arranged in the first inner cavity, the second inner cavity is communicated with the through hole, and the suture line catching device is arranged in the second inner cavity.

Further, the suture catch device includes a distal catch element, an extension filament connected to the distal catch element, and a proximal catheter, the extension filament being disposed within the proximal catheter and slidable relative to the proximal catheter.

Further, the distal capture element comprises a capture loop or a capture clip.

Further, the catching ring is made of a nickel-titanium alloy material or a high polymer material.

Further, the piercing catheter includes a tubular portion and a piercing portion, the tubular portion being connected to the piercing portion, the tubular portion being located at the proximal end and the piercing portion being located at the distal end.

Further, the tubular part is made of a high polymer material, and the puncturing part is made of a metal material.

Further, the penetrating portion includes a main body segment, a bendable segment, and a needle body segment connected in sequence from a proximal end to a distal end.

Furthermore, one side of the bendable section is provided with an opening or a groove.

Further, a spiral opening or a spiral groove is arranged on the bendable section, and the width of the spiral opening or the spiral groove along the axial direction of the opening or the groove on one side of the bendable section is larger than the width of the opening or the groove on the other side of the bendable section along the axial direction.

Further, the suturing device further comprises a knotter, and the knotter is provided with a knotter through hole.

Further, the knotter material is silica gel or rubber.

Further, be provided with the arch on the inner wall of knotter through-hole, the arch is followed the inner wall of knotter to the center pin direction of knotter through-hole extends, the direction that extends with the contained angle of the inner wall of knotter through-hole is less than 90 degrees.

According to the suture device, the puncture catheter and the suture line catching device are arranged in the tubular catheter, the through hole is formed in the wall of the tubular catheter, and the suture line catching device is pushed out of the through hole to catch the suture line.

Drawings

Fig. 1 is a schematic diagram of a patent foramen ovale closed by using a metal occluder in the prior art.

FIG. 2 is a schematic view of a suturing apparatus according to one embodiment.

FIG. 3 is a schematic view of a proximal radial cross-section of a tubular catheter according to one embodiment.

Fig. 4 is a schematic view of a suture capture device provided in accordance with an embodiment.

Fig. 5 is a schematic view of another state of the suture catch device according to an embodiment.

FIG. 6 is a schematic view of a piercing catheter provided in accordance with one embodiment.

FIG. 7 is a schematic view of the distal piercing portion of one embodiment of a piercing catheter.

Fig. 8 is a schematic view of a knotter according to an embodiment.

Fig. 9 is a sectional view of the knotter of fig. 8.

Fig. 10 is an enlarged view of fig. 9.

FIG. 11 is a flow chart illustrating a method for suturing a patent foramen ovale according to an exemplary embodiment.

FIG. 12 is a schematic view of a tubular conduit through a primary septum according to one embodiment.

FIG. 13 is a schematic view of one embodiment providing a bend in the piercing catheter.

FIG. 14 is a schematic view of one embodiment of a puncture catheter being inserted through the primary septum and the secondary septum.

FIG. 15 is a schematic view of one end of a suture being introduced into a body, according to one embodiment.

Fig. 16 is a schematic view of an embodiment providing a suture capture device capturing one end of a suture.

FIG. 17 is a schematic view of one end of a suture returning to the outside of the body, according to one embodiment.

FIG. 18 is a schematic illustration of retaining only sutures in vivo, according to an embodiment.

FIG. 19 is a schematic view of a knotter securing suture according to one embodiment.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

First, it is emphasized that reference to "proximal" in the context of embodiments of the present invention refers to the end that is closer to the operator during operation; "distal" means the end that is distal to the operator during operation; "axial" refers to a direction parallel to the line joining the center of the distal end and the center of the proximal end of the medical device; "radial" refers to a direction perpendicular to the axial direction.

An embodiment of the present invention provides a suture device, including a tubular catheter, a puncture catheter, and a suture line catching device, where the puncture catheter and the suture line catching device are disposed in the tubular catheter and can slide along an axial direction of the tubular catheter, a through hole is disposed on a wall of the tubular catheter, and the suture line catching device can be pushed out of the through hole.

The suturing device can be used for suturing patent foramen ovale, blood vessel, atrial septal defect, ventricular septal defect and the like.

See below for details.

As shown in FIG. 2, the suturing device 100 includes a tubular catheter 21 and a puncture catheter 22, the outer wall 210 of the tubular catheter 21 has a through hole 211, and the puncture catheter 22 is disposed in the tubular catheter 21 and slides along the axial direction of the tubular catheter 21. In this embodiment, the through hole 211 is located near the distal end of the outer wall 210 of the tubular catheter 21, and in other embodiments, the through hole 211 may also be located at the middle position of the outer wall 210 of the tubular catheter 21.

Referring to fig. 2 and 3, fig. 3 is a schematic view of a proximal radial cross section of the tubular catheter 21 provided in the present embodiment, and the tubular catheter 21 is provided with a first inner cavity 212 and a second inner cavity 213 inside. The first lumen 212 extends distally along the proximal end of the tubular catheter 21 until completely penetrating to the distal end; the second inner cavity 213 penetrates to the through hole 211 along the proximal end of the tubular catheter 21 and is stopped, and the second inner cavity 213 and the through hole 211 are communicated with each other to form a passage. In this embodiment, the puncture catheter 22 is disposed within the first lumen 212 and the second lumen 213 is used to provide access to the body for the suture catch device 40 (see FIG. 15).

The suturing device 100 also includes a suture catch 40. Referring to fig. 4 and 5, suture capture device 40 includes a proximal catheter 41, a distal capture element 42, and an elongate wire 43, where the elongate wire 43 is attached to the distal capture element 42, the elongate wire 43 is disposed within the proximal catheter 41 and slides relative to the proximal catheter 41, pushing or pulling the distal capture element 42 out of or into the proximal catheter 41. The proximal catheter 41 is made of polymer material, and may be a stainless steel or nitinol tube. The material of the extending wire 43 is nitinol or stainless steel.

In this embodiment, the distal capture element 42 is a capture loop. The catching ring is made of elastic material and can be made of nickel-titanium alloy or high polymer material, so that the original shape can be automatically recovered after compression deformation. The capture loop has a compressed state and an expanded state. In fig. 4, the capture ring is in the deployed state when exposed to the proximal catheter 42; in fig. 5, the capture loop is compressed as it enters the proximal catheter 41, and when the elongate wire 43 is retracted in the direction indicated by the arrow, the elongate wire 43 and the distal capture element 42 move relative to the proximal catheter 41, and the capture loop is correspondingly compressively deformed to progressively retract into the lumen of the proximal catheter 41, thereby progressively reducing the capture loop exposed at the proximal catheter 41 until it eventually locks the suture thread passing therethrough. In other embodiments, the distal capture element 42 may also be a capture clip, it being understood that once the capture clip has gripped an end of the suture, it locks the end of the suture and then enters the proximal catheter 41.

Referring to fig. 6, the puncture catheter 22 is a hollow structure that is a passage for delivering a suture to the body. The puncture catheter 22 includes a tubular portion 221 at a proximal end and a puncture portion 222 at a distal end, the tubular portion 221 being connected to the puncture portion 222. In this embodiment, the material of the tubular portion 221 is a polymer material, which has good flexibility, and this property can make it easier to push the puncture catheter 22 along the inner cavity of the tubular catheter 21; the piercing portion 222 is made of a metallic material having sufficient rigidity, preferably nitinol. The tubular portion 221 and the piercing portion 222 are joined by a joining method such as glue bonding or laser welding.

In fig. 7, the piercing portion 222 includes a main body segment 230, a bendable segment 232, and a needle body segment 231, which are connected in series. In the present embodiment, an opening 233 communicating with the lumen of the puncture catheter 22 is formed on one side of the bendable section 232, and the bendable section can be bent after the restriction of the external force is released. In other embodiments, a slot is formed in one side of the deflectable segment 232, i.e., the slot does not communicate with the lumen of the piercing catheter 22. It is understood that in other embodiments, one side of the bendable section 232 may be simultaneously provided with the opening 233 and the slot.

It is understood that in other embodiments, the bendable section 232 is provided with a helical opening or a helical groove, and the width of the helical opening or the helical groove in the axial direction at one side of the bendable section 232 is larger than the width of the opening or the helical groove in the axial direction at the other side of the bendable section 232, so that the bendable section 232 bends toward one side. Needle body segment 231 is wedge-shaped and has a relatively sharp head that can penetrate the atrial septum.

In other embodiments, the piercing portion 222 may not include the bendable section 232, only the body section 230 and the needle section 231.

The suturing device also includes a knotter 50. Referring to fig. 8 and 9, in the present embodiment, the knotter 50 is a cylindrical structure, and in other embodiments, the knotter 50 may have other shapes such as a sphere, a polyhedron, and the like. The knotter 50 has two knotter through

holes

51, 52 through which the two knotter through

holes

51, 52 are respectively passed by both ends of the suture thread, and the diameter of the two knotter through

holes

51, 52 is slightly smaller than that of the suture thread. The knotter 50 is made of flexible material, preferably silica gel or rubber. When the suture line fixing device is installed, the suture line can pass through under certain pushing force, the knotter 50 stops when being pushed to a target position close to the interatrial septum, and the knotter 50 has certain resilience force, so that the suture line 30 is locked and fixed. Or, the inner walls of the knotter through

holes

51 and 52 are provided with bulges with certain shapes, so that the suture thread is stressed less when passing through in the positive direction and stressed more when sliding in the reverse direction, and the aim of locking the suture thread is fulfilled. It is understood that, in the present embodiment, the number of the knotter through holes in the knotter 50 may be 1 or more.

As shown in fig. 10, reference numeral 53 denotes the above-mentioned protrusion of the inner wall of the through hole of the knotter, and the material thereof may be the same as that of the knotter. The knotter is characterized in that the knotter extends from the inner wall of the through hole of the knotter to the direction of the central axis of the through hole of the knotter, and the included angle M between the extending direction of the knotter and the side line of the inner wall of the through hole of the knotter is smaller than 90 degrees. Define the A end as the penetrating end of the suture and the B end as the penetrating end of the suture. When the suture passes from the end a to the end B, the projection 53 is pressed by the suture, and is rotationally deformed in the clockwise direction, and the angle M is reduced. At this time, the projection 53 is gradually brought close to the inner wall of the through hole of the knotter, so that the resistance to the passage of the suture is reduced and the suture can pass smoothly. When the suture is reversed, the protrusion 53 is reversely rotated in the counterclockwise direction, the angle M is increased, the suture is gradually blocked from passing, and finally, the locking effect is achieved.

Referring to fig. 11, an embodiment of the present invention provides a method for suturing a patent foramen ovale by the suturing device 100, which includes the following steps:

s101, the distal end of the tubular catheter penetrates through the primary septum to the left atrium;

s102, pushing out the puncture catheter, wherein the far end of the puncture catheter sequentially penetrates through the primary septum and the secondary septum to reach the right atrium;

s103, one end of the suture is sent into the body along the puncture catheter to the right atrium;

and S104, arranging a through hole on the wall of the tubular catheter, and pushing the suture catching device out of the through hole to catch one end of the suture.

Before step S101, the method for suturing a patent foramen ovale further includes: puncturing the primary septum to the left atrium by using an interatrial septum puncture needle, feeding the distal end of the guide wire into the left atrium along the inner cavity of the interatrial septum puncture needle, withdrawing the interatrial septum puncture needle, and keeping the guide wire; in vitro, the proximal end of the guide wire is inserted into the puncture catheter from the distal end of the puncture catheter and is penetrated out from the distal end of the puncture catheter, the puncture catheter is inserted into the tubular catheter again, and then the tubular catheter containing the puncture catheter is conveyed into the right atrium along the guide wire. It is emphasized that the transseptal needle is not the puncture catheter in the suturing device, but is a conventional needle.

In step S101, referring to fig. 12, the distal end of the tubular catheter 21 is passed through the primary septum 4 to the left atrium, at which time the penetrating catheter 22 is in the first lumen 212 of the tubular catheter 21.

In step S102, referring to fig. 13 and 14, after the distal end of the puncture catheter 22 is pushed out of the tubular catheter 21, the tubular catheter 21 releases its external restraint on the puncture catheter 22, the puncture catheter 22 is bent, the tubular catheter 21 is kept still, the puncture catheter 22 is retracted in the proximal direction of the tubular catheter 21, and the distal end of the puncture catheter 22 sequentially pierces the primary septum 4 and the secondary septum 3, so that the needle body 231 of the puncture catheter 22 reaches the right atrium. In this embodiment, the puncture catheter 22 is bent 180 degrees, and in other embodiments, the puncture catheter 22 is bent 90 to 180 degrees, excluding 90 degrees, preferably 180 degrees, to facilitate puncturing of the interatrial septum by the puncture catheter 22.

In step S103, in FIG. 15, suture 30 is advanced from outside the body along the lumen of puncture catheter 22 until the distal end of suture 30 extends from the distal end of puncture catheter 22. In this embodiment, the suturing device 100 can further include a suture 30, wherein the suture 30 includes a length of guide wire and a length of medical suture, and the guide wire is connected with the medical suture. The connection mode of the guide wire and the medical suture can be preferably glue bonding.

It is emphasized that the internal structure of the tubular catheter 21, including the first and second lumens and the suture catch device, which are all integral parts of the suturing device, have been omitted from fig. 13, 14 and 15 to make the drawings more concise.

In step S104, in fig. 16, the suture line catching device 40 is pushed along the second lumen 213 of the tubular catheter 21, the distal end of the proximal catheter 41 of the suture line catching device 40 extends from the through hole 211 of the tubular catheter 21 to the right atrium, and then the extension wire 43 of the suture line catching device 40 is pushed so that the distal catching element 42 of the suture line catching device 40 is exposed to the proximal catheter 41 and is in a deployed state, and the suture line 30 is pushed so that the distal end of the suture line 30 passes through the middle of the distal catching element 42, thereby achieving catching. It is again emphasized that the second lumen of the tubular catheter has been omitted from figure 16 for the sake of simplicity of the drawing, all of which are integral parts of the suturing device.

After step S105, referring to fig. 17 to 19, the method for suturing a patent foramen ovale further includes: withdrawing the suture catch device until the suture catch device is withdrawn from the proximal end of the tubular catheter 21 out of the body, at which point the distal end of the suture 30 extends out of the body; then, withdrawing the puncture catheter 22 and the tubular catheter 21 in sequence, leaving only the suture 30 at the interatrial position; the knotter 50 is pushed to the position close to the interatrial septum along the two ends of the suture line 30 extending outside the body and is locked; and (4) cutting off redundant suture lines by using a thread cutting device, and finally finishing the closure of the Patent Foramen Ovale (PFO). It is again emphasized that the second lumen of the tubular catheter has been omitted from figure 17 in order to make the figure more concise, all of which are integral parts of the suturing device. The length of the suture thread is set as needed as long as it does not interfere with the withdrawal of the puncture catheter and the tubular catheter from the body.

In other embodiments, when the piercing portion 222 does not include the bendable section 232, only the body section 230 and the needle section 231, the suturing method differs from the above-described suturing method in that: in step S102, the puncture catheter is pushed out so that the distal end of the puncture catheter is held in the left atrium; in step S103, one end of a suture thread is fed into the body along the puncture catheter to the left atrium, and then the puncture catheter and the tubular catheter are sequentially withdrawn out of the body along the suture thread, one end of which remains in the left atrium; in step S104, the distal end of the tubular catheter is passed through the septum to the left atrium, and a through hole is provided in the wall of the tubular catheter, and the suture thread catching device is pushed out of the through hole to catch one end of the suture thread remaining in the left atrium. It will be appreciated that in this step S104, the distal end of the tubular catheter is passed through the septum before passing through the septum to the left atrium by puncturing the septum with a puncture needle. Other steps are the same as those in the previous embodiment, and are not described herein again.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A suturing device is suitable for suturing patent foramen ovale, atrial septal defect and ventricular septal defect, and is characterized by comprising a tubular catheter, a puncture catheter and a suture line catching device, wherein the puncture catheter and the suture line catching device are arranged in the tubular catheter and can slide along the axial direction of the tubular catheter; when the puncture catheter is pushed out from the tubular catheter and is in a bent state, the needle body section is positioned at the far end of the through hole.

2. The suturing device of claim 1, wherein a first lumen and a second lumen are disposed within the tubular catheter, the first lumen extending distally along the proximal end of the tubular catheter, the puncture catheter being disposed within the first lumen, the second lumen being in communication with the through-hole, the suture catch device being disposed within the second lumen.

3. The suturing device of claim 1, wherein the suture capture device comprises a distal capture element, an elongate filament connected to the distal capture element, and a proximal catheter, the elongate filament being disposed within the proximal catheter and slidable relative thereto.

4. The suturing device of claim 3, wherein the distal capture element comprises a capture loop or a capture clip.

5. The suturing device of claim 4, wherein the capture ring is a nickel titanium alloy material or a polymeric material.

6. The suturing device of claim 1, wherein the puncture catheter further comprises a tubular portion connected to the puncture portion, the tubular portion being located at a proximal end and the puncture portion being located at a distal end.

7. The suturing device of claim 6, wherein the tubular member is formed of a polymeric material and the penetrating member is formed of a metallic material.

8. The suturing device of claim 1, wherein the flexible segment is open or slotted on one side.

9. The suturing device of claim 1, wherein the bendable section is provided with a helical opening or a helical groove, the helical opening or helical groove having a greater width in the axial direction at one side of the bendable section than at the other side of the bendable section.

10. The suturing device of claim 1, further comprising a knotter having a knotter throughbore.

11. The suturing device of claim 10, wherein the knotter material is silicone or rubber.

12. The suturing device of claim 11, wherein a protrusion is provided on an inner wall of the knotter through-hole, the protrusion extending from the inner wall of the knotter toward a central axis of the knotter through-hole, and an angle between the extending direction and the inner wall of the knotter through-hole is less than 90 degrees.